Recall Z-2448-2026— Steris Corporation
Class II · Ongoing
Class II FDA medical device recall by Steris Corporation, initiated 2026-05-15. FDA's recall record names no specific 510(k) clearance for this event. Product: HarmonyAIR A-Series Surgical Lighting System. Reason: There is a potential for paint delamination (chipping/peeling) on the lighting system's light heads..
- Recalling firm
- Steris Corporation
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-05-15
- Firm location
- Mentor, OH, United States
Product description
HarmonyAIR A-Series Surgical Lighting System
Reason for recall
There is a potential for paint delamination (chipping/peeling) on the lighting system's light heads.
Data sourced from openFDA. This site is unofficial and independent of the FDA.